Medline Industries, LP: DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
Read the official notice at FDA (device) →
Get alerts for Medline Industries
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
- Reason / hazard
- Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;
- Recall initiated
- 2025-10-10
- Code info
- CYSTO DYNJ909127F UDI-DI 40198459055424 (case), 10198459055423 (ea) Lots 25FBP819 25GBM605; GENERAL LAPAROSCOPY-LF DYNJ909129D UDI-DI 40198459055264 (case), 10198459055263 (ea) Lots 25FBV537; ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909119G UDI-DI 40198459130527 (case), 10198459130526 (ea) Lots 25FBP681
- Product quantity
- 96,406 total units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 97882
Free daily digest + "My products" watchlist